510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K153519Substantially Equivalent

DReal

Carevature Medical, Ltd., Tel Aviv, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K153519 is the FDA 510(k) clearance record for DReal, a class II device, cleared for Carevature Medical, Ltd. on under FDA product code HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered)). FDA records list one 510(k) clearance for Carevature Medical, Ltd. As of , FDA records show no recalls naming K153519.

Clearance record

Decision date
Received
(99 days to decision)
Product code
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Regulation
21 CFR 882.4310
Device class
Class II
Review panel
Neurology
Applicant
Carevature Medical, Ltd. 42 Tvuot Haarets St., Tel Aviv, IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HBE

Trailing 12 months
2 clearances under product code HBE in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HBE, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260